DQ, IQ, OQ, PQ FOR BIOMETRIC SYSTEM

1.0 DESIGN QUALIFICATION
1.1 Define the Biometric Technology Used. It’s Principle and Capturing System. E. g

1.2 Define the Extraction and Comparison Process
Specify how the system will extract the captured data and convert into mathematical Code /template for comparison purpose.
Specify the threshold value for the purpose of comparison.
1.3 Define Vendor Qualifications for Biometric System.
- Number of Biometric System installed.
- Types of the technology used.
- Type of post marketing feed back received by him.
1.4 Define Final Specifications and Acceptance Criteria agreed between Vendor and User.
- Technology to be used.
- Capturing device to be used.
- Extraction and Comparison system to be used.
- Threshold value for the match.
- Maximum Failure rate (False Rejection, False Acceptance) per day.
2.0 IQ FOR BIOMETRICS
2.1 Check the computer system where it will be installed.
- Check the drive.
- Check the space required.
- Check the ancillary softwares required on Computer.
- Check the power supply.
- Check the dust controls procedures used in the room where system is to be installed.
- Check whether the system meets the agreed specifications.
3.0 OPERATIONAL QUALIFICATION
3.1 Define the SOP for Biometrics.
3.2 Check the password, which may be required to activate the system.
After activation check if the system is ready to scan, extract and compare the specified biometric feature.
3.3 Check for operation manual, maintenance, and calibration manuals.
4.0 PERFORMANCE QUALIFICATION
Try excess to the computer system by exposing required biometric feature to the machine
Record the results as per follows

Please Note
Specify the conditions of scanner plate during PQ ( It should be free from dust and smudges.
Specify integrity of biometric feature (The body part which is used by the system shall be intact. It shall not be cut, bruised, or damaged. For Example, if entire Finger is used, it shall not have cuts).
5.0 ACCEPTANCE CRITERIA
- Failure to activate the screen : Nil
- False Rejection : Nil
- False Acceptance : Nil
6.0 VALIDATION REPORT
- Describe the DQ, IQ, PQ, and OQ briefly.
- Describe the SOP followed for PQ
- Compare the results against the acceptance criteria.
- Conclude – System is satisfactory. System needs improvement and revalidation.
7.0 SOP’S for the Biometric System based on Finger Technology.
• Activate log on screen.
• Check the scanner plate.
• Clean it if there is smudging.
• Clean the left index finger, wipe it dry and expose the required area/ part to scanner plate.
• Wait for response.
• If allowed, proceed with you work.

DESIGN INPUTS FOR NEW COMPUTER SYSTEMS

CHECKLIST-Design Inputs for New Computer Systems
A Purpose of System
i) Clear statement of what the system is to do.
ii) Expected benefits.
iii) Relation to other system.
1.0 Controlled Function
1.1 Operating Modes
a) Automatic mode.
b) Manual mode.
c) Maintenance mode.
d) Operational interlocks.
1.2 Description of Operations.
a) Sequence of operation.
b) Modifiable parameters.
c) Limiting conditions.
1.3 Controlled elements.
a) Valves, heaters, motors……
b) I\P, relays, solenoids, motor starters ….
2.0 Computer System
2.1 Hardware.
a) CPU
b) Memory devices.
c) Recording devices.
d) Communication interfaces.
e) Operator terminals
2.2 Software
a) Operating System
b) Communication drivers.
c) Network Controllers.
d) Configurable Programs.
e) Application Programs
3.0 Information Input
3.1 Measured Inputs
a) Number, Type, and location of each sensor.
b) Type, Model Number, and software version of all transducers and
signal converters.
c) Model number and software version of all analog input modules.
d) Tag name, location, data type, and valid range of all analog inputs.
3.2 Discrete Inputs
a) Type, model number, and software version of all discrete input modules.
b) Tag name and location of all discrete inputs.
3.3 Operator Inputs
a) Entry and verification means.
b) Entry modes.
c) Error detection.
d) Error correction
e) Tag name, description, and range of parameters.
f) Electronic Signatures.
3.4 Recipe Inputs
a) Definition.
b) Loading.
c) Verification.
d) Security.
g) Tag name, description, and range of parameters.
e) Electronic Signatures.
3.5 Input from other Systems.
a) Source.
b) Communication mode.
c) Error detection.
d) Error correction
e) Tag name, description, and range of parameters.
4.0 Material Input
4.1 loading
a) Manual Loading.
b) Automatic loading.
c) Input from other system.
4.2 Checks on Material Inputs
5.0 Data Processing
5.1 Input Data
a) Data conversions.
b) Scaling.
c) Calibration means.
d) Error detection and correction.
5.2 Calculations.
a) tag names and input parameters.
b) Algorithms.
c) Control strategies.
d) Tag names and ranges of output parameters.
e) Error detection and correction.
6.0 Information Output
6.1 Control
a) Tag name, location, range, and default value of analog outputs.
b) Model number, software version, and location of each analog output Module.
c) Type, model number, software version, and location of each output driver.
6.2 Alarms
a) Tag name, type, and location of alarm outputs.
b) Type and location of alarm indicator.
c) Acknowledgement means.
6.3 Displays
a) Tag name of the data values.
b) Tag name of status indicators.
c) Event indicators
d) Alarm indicator.
6.4 Printed Reports.
a) Tag name of the data values.
e) Tag name of status indicators.
f) Event recording.
g) Alarm recording
h) Report generation
6.5 Transmission to other systems.
a) Tag name of the data values.
b) Tag name of status indicators.
c) Event Transmission.
d) Alarm transmission
e) Report transmission.
f) External request of data.
6.6 Archived Data
a) Tag name of the data values.
b) Tag name of status indicators.
c) Event recording.
d) Alarm recording
e) Report generation
f) Audit trail.
7.0 Operational Features.
7.1 Alarm Management.
a) Action.
b) Priority.
c) Reporting.
d) Acknowledgment.
e) Power failure.
7.2 Security
a) Levels
b) Means of access.
c) Parameter modification.
d) Program access.
7.3 Safety
a) Physical Interlocks.
b) Software interlocks.
c) Emergency shutdown and recovery.
7.4 System Failure.
a) Failure Modes
b) Default state
c) Recovery modes.
7.5 Analog data update Time
a) control inputs
b) alarms
c) Displays.
d) Reports.
e) Archived data.
f) Transmission to other system.
7.6 Discrete data update time
a) Control outputs.
b) Alarms.
c) Displays.
d) Reports.
e) Archived data
f) Transmission to other systems.
7.7 Response to operator inputs.
a) Analog.
b) Discrete
c) Alarm.
8.0 Physical Requirements
8.1 System Structure.
a) Layout of components.
b) Relation to facilities and other systems.
8.2 Size Restrictions.
8.3 Materials.
a) Type.
b) Finishes.
8.4 Utilities.
a) Electrical.
b) Water.
c) System
d) Air.
8.5 Environmental.
a) Temperature.
b) Vibration.
c) Electrical interference.
d) Humidity.

OPERATION AND CLEANING OF PACKING LINE

1.0 PURPOSE
This procedure is provide a documented procedure and this procedure is Labelling and Packing department of production in Operation and Cleaning Process.
2.0 SCOPE
This procedure is applicable to procedure of Operation and Cleaning of Packing Line in packing department at Vital Healthcare.
3.0 RESPONSIBILITY
It is responsible for production chemist / packing supervisor.
4.0 PROCEDURE
4.1 Pre Start Up
a) When same batch of the same product is to be continued from the previous shift.
b) Ensure that the packing material of the same batch is kept near the line.
c) When new pack of the same batch No. or new batch No. of same product or different product is to be taken on the packing line.
d) Physically check the cleanliness of the packing line as per the packing line clearance.
e) Record the previous product batch details and next product batch details in the space specified.
f) Get the line clearance checked by production supervisor and cleared by Quality Assurance supervisor and file in Batch Packing Record.
g) Arrange the tote box containing printed materials and pellets containing other packing components near the packing line.
4.2 Start Up
a) Switch “ON” the main electric supply.
b) Switch “ON” the packing belt.
4.3 Operation
Start feeding the material to be packed on the belt and continue the packing.
4.4 Shut Down
a) Stop feeding the material to be packed on the line.
b) Switch “OFF” the plug line.
c) Switch “OFF” the main electric supply.
4.5 Cleaning Procedure
A) End of the shift.
i) Clean the packing belt, side table and end tables.
ii) Clean the drive below belt to remove any material trapped in the drive or belt.
iii) Keep the packing to material and containers of product in proper place with status label.
iv) Send the rejected strips or blisters to the process area through the material entry air lock with status label.
v) Count the wastage of printed material during packing at the end of the shift and destroy than. Record the wastage and quantity of good packed material.
vi) Remove date, shift and packer code stores from the drum of shipper code.
B) Batch / Product / Pack Change Over
i) Remove the left over material from the packing line after affixing the status label.
ii) Remove the BOPP tape from the carton sealing machine. If tape to be used for the next product is different.
iii) Clean the packing line and ensure that none of the remnants is stuck any where on packing line.
iv) Ask the house keeping person to clean the surrounding floor.
5.0 REPORTING
5.1 Enter the operating and cleaning details in “Labelling Machine Operation and Cleaning Log Book”.
5.2 For any problem or deviation report to APM.
6.0 REFERENCE DOCUMENTS
PRD/ XXX / R / 03 / 03 Machine Operation and Cleaning Log Book.
PRD/XXX/O/O3/01 SOP for Line Clearance.
7.0 REVIEW
After two years or when procedure is changed.

SOP: VACCUM PUMP

Remov Contaminated Oil
1) Run pump for a few minutes to heat up the oil. Stop pump.
2) Place a 2-3 inch wooden block under the end opposite the drain valve.
3) After completely draining the contaminated oil, pour equivalent quantity of fresh oil into the intake port.
4) Open exhaust port and operate pump for about 1 minute with the intake port alternately open and closed to circulate the fresh oil.
5) Repeat above steps as many times as necessary until you flush clean oil from the pump.
6) Fill with clean oil to the indicated level.
7) Start the pump and check for
a) Operating pressure
b) Leaks in the system
If leak is suspected check each hose clamp and equipment’s at the joints to make sure they are tight.
Please Note :
Check for proper connectivity of vapour trap
This will prevent release of vapours in to atmosphere.

USE OF FLUID BED DRYER

1. It should be ensured that the drier is clean and ,fit for use (see document entitled "Cleaning of Fluid Bed Drier).
2. The cleaned bags should be examined to ensure that they are free from holes and other defects.
3. The finger sleeves of the bag should be fixed to the respective hooks on the holding ring. The bag support frame should be inserted and the filter bag unit should be clipped to the retaining strap.
4. The cleaned bowl of the drier should be examined to ensure that the inner surface is clean and that there is no damage to the wire mesh sieve at the bottom. The bowl should be labeled with the name and batch number of the product being processed.
5. The wet material (to be dilled) should be loaded into the bowl and the mass spread uniformly. The trolley carrying the bowl should then be wheeled in and positioned beneath the sealing ring in such a way that the sight glass is in the front and the bowl raising lever on the base is accessible.
6. The earthling should be clamped on to one of the legs of the bowl trolley or alternately, it should be ensured that the bowl comes in contact with the eat1hing strap when pushed into position.
7. The bowl should be raised with the help of the lever. Where a pneumatic device is provided on the machine, it should be ensured that the bowl gets locked in position . and the bags are also held in place.
8. The heater should be switched on and the temperature setting on the thermostat adjusted to the required inlet air temperature. Where a time switch is provided the drying time should be set by turning the knob clockwise to the extent required.
9. The dampers should be adjusted to the required level and the locking nuts tightened to keep the dampers in place.

PROCEDURE FOR BLENDER GRANULATION

Check the blender status.

It shall be clean and ready for use.

In case it is not clean, get the same cleaned and ready for use.

1.0 If the materials required for a batch are dispensed from a central dispensary, all the weighed materials should be collected as one batch per pallet (wherever possible.) The pallet should be clean and no material should be received in dirty containers or in the original containers of the suppliers.

2.0 Each raw material from the central dispensary should be weighed to verify the gross weight indicated by the dispensing depat1ment.

3.0 Any discrepancies in the weight should be suitably rectified.

4.0 The weights should be recorded on the manufacturing sheets and countersigned by the supervisor.

5.0 If the materials are dispensed from the stores, they should be weighed on appropriate scales with adequate capacity and sensitivity (see document entitled Weighing of Materials ).

6.0 It must be ensured that materials in their original or other containers are not contaminated by the measuring and dispensing devices such as scoops, spoons, etc. Each material should be handled by means of its own dispensing device; all such equipment used for handling the materials should be cleaned immediately after each use and kept aside covered in plastic.

7.0 All materials should be weighed into clean, tared and labeled containers, The balance of material not dispensed should be returned to the bulk stock.

8.0 Weighed materials should be transferred to the blending area which should be separate from the weighing area.

9.0 The ingredients for the batch should be added to the mixer through suitable sieve, if needed. After the addition is over, the blender shall be covered.

10 Operate the blender for the rquired time at required rpm.

11 Check the speed of the rotor .

12 After the required blending has been achieved, stopp the blender.

13 Remove the contents manually or by tilting into clean polythene bags.

14 Clean the blender to remove all residues.Cover it with Polythene Cover

For next operation.

PROCEDURE FOR SPARKLER FILTER

1.0 INTRODUCTION
In the final stages of manufacture of bulk drugs, it is necessary to clarify the reaction mixture to remove extraneous and other suspended matter which may be present. This is done by means of filtration of the reaction mixture. This document gives the procedure for clarification of reaction mixtures by filtration through horizontal plate filters.
2.0 PRECAUTIONS
a) It is advisable to use freshly boiled and cooled purified water .
b) The suitability of the filter paper and filter cloth used for filtration must be ascertained before use.
c) It must be ensured that flexible tubings used in the filter asembly have been cleaned. Where they have been stored away after cleaning, the open ends should have been covered with polythene sheets. If this has not been done or there is evidence of dust on the tubings, they should be cleaned and dried before use.
3.0 SETNNG OF THE FILTERATION MACHINE
a) All the removable parts of the filter assembly should be cleaned with hot water and steam. Hot water should be passed through flexible tubings followed by steam. The water should then be drained out.
b) The filter plates should then be assembled with the cloth filters or papers in place. The battery of filters should then be positioned in the filter chamber and the lid should be fitted.
c) The required lengths of flexible tubing should then be attached to both ends of the filter assembly.
d) The required quantity of filter aid or clarifying agent should be suspended in a suitable quantity of purified water. After it is uniformly mixed it should be pumped into the filter and circulated through the filter unit until a uniform bed is formed on the filter and the water coming out of the outlet end of the assembly is clear .
e) The bed should be washed with fresh quantities of purified water until the pH of the water from the outlet is the same as that of the feed water (range 5.5 to 6.5)
f) The pump should be stopped and the water in the filter assembly should be drained out.
4.0 FILTERATION PROCESS
4.1 The inlet tubing should be dipped into the product to be filtered. The outlet tubing should be placed in a clean container and the pump should be started.
4.2 The air vent should be closed after air is removed from the assembly and the liquid starts flowing thorough the outlet tube.
4.3 The first few liters of liquid should be discarded as it normally consists of the product diluted with water trapped in the filter assembly.
4.4 The clarity of the first few litres should be checked and if found satisfactory, the filtered liquid should be returned to the main product tank.
4.5 Filtration should continue and the clear product should be collected in a clean dry tank. During filtration the clarity of the liquid should be checked at suitable intervals.
4.6 If the clarity is not satisfactory at any stage, the collection of filtered liquid should be stopped and the liquid in the assembly should be returned to the main tank.
4.7 The filter should be re-set as described
4.8 After filtration is over, the inlet valve should be closed and the pump stopped immediately. Pressure should be applied through the air vent and the filtrate should be collected and added to the main filtered bulk.
4.9 When air starts coming out, the outlet value should be closed and the trapped liquid in the assembly should be collected through the scavenger outlet.
4.10 Liquid coming through the scavenger outlet should be checked for clarity before adding it to the main filtered bulk.
4.1 The electrical connections should be removed and the tubings and filter assembly should be taken away for washing.

PROCEDURE FOR USING D.G. SET

1.0 PURPOSE

This SOP describes the procedure of using D. G. Set.

2.0 RESPONSIBILITY

Responsibility of this operation is with maintenance department.

3.0 PROCEDURE

a) Check battery voltage.

b) Check suction air filter.

c) Check lubricant oil in oil pan.

d) Check diesel level in service tank.

e) Check water level in Radiator.

f) Check V belts.

g) Check the cleaning of Radiator.

h) Confirm that the capacitors of main panel are off.

i) Insert the key in control panel and press the bypass (yellow) button with one finger and press Green Start button for few seconds and release .DG will get started .DO NOT PRES GREEN BUTTON ONCE DG STARTS.

j) Check oil pressure. temperature.

k) Check speed , it should be 1500 rpm.

l) Check frequency, it should be 49.5 to 50.5 cps.

m) Check voltage and current.

PROCEDURE FOR USING CHILLING COMPRESSOR

1.0 PURPOSE
This SOP describes the procedure of using Chilling Compressor

2.0 RESPONSIBILITY
Responsibility of this operation is with maintenance department.

3.0 PROCEDURE

a) Check voltage on panel . it should be 400 v to 440 v

b) Check oil level .

c) Ensure suction valve is closed and discharge valve is open.

d) Check ammonia level in tank.

e) Start condenser cooling pump.

f) Check inlet valve of condenser cooling, inlet cooling of jacket and outlet valve of jacket cooling are open.

g) Check brine level in brine tank and specific gravity of brine.

h) Start brine pump.

i) Start compressor and wait till comes on load .

j) Open suction valve and check suction pressure.

k) Check oil pressure ,it should be 1 kg/cm2 above suction pressure.

l) Check suction delivery and oil pressure every two hours.

PROCEDURE FOR USING BOILER

1.0 PURPOSE
This SOP describes the procedure of using Boiler.
2.0 RESPONSIBILITY
Responsibility of this operation is with maintenance department.
3.0 PROCEDURE
a) Check water quality and water level in the service tank.
b) Check feed water pump for leakage.
c) Check oil pump.
d) Check fuel oil level in the service tank.
e) Close main steam valve and start feed water.
f) Open bypass valve and ensure that water is passing through blow down line.
g) Start burner, temp will start rising ,when steam goes out of blow line close bypass valve.
h) Pressure starts rising and boiler will get cut off at 10 kg/ cm2
i) Give blow down and observe blow down time.
j) Repeat steps ( f) to (i).
k) Open main steam valve to plant.
l) Check smoke color and adjust blower and oil pressure.
m) Note down pressure, temperature, oil pressure every hour.
n) Give blow down after every 4 hours.
o) After closing the boiler do not forget to cool it for 30 min. by circulating water.

OPERATION OF FLUID BED DRYER

1.0 Preferred room temperature should be around 25°C.

2.0 Fix all the fingers of the dryer bag securely to the apex which must be earthed. Do not patch up the tom bag by a synthetic cloth. It is dangerous from electrostatic hazard point of view.

3.0 Check that the bowl is free of a metal piece. The frictional spark could be externally dangerous. Lift the bowl pneumatically.

4.0 Check that all the detachable parts of the dryer are properly earthed.

5.0 Start the dryer, if there exists any discontinuity electrically the interlocking would not actuate starting of the dryer. Do not make short cuts by isolating the safety device.

6.0 Run the dryer for 15 minutes with cold air only. Start heating of air by hot water / steam only.

7.0 Monitor fluidization of the batch and maintain specified temperature of air inlet and outlet.

8.0 Beware of the hazard due to sharp pointed spikes hanging in the expansion chamber while cleaning dryer from inside. Use helmets while cleaning. Use only flame proof torch whenever necessary. Keep the area clean and free of chemical dust.

9.0 Use hand gloves, dust mask and goggle while shoveling the batch, charging and discharging of the dryer.

OPERATING PROCEDURE FOR PRESSURE QUARTZ FILTER

1.0 AIM
To lay down a standard operating procedure for pressure quartz filter.
2.0 SCOPE
Maintenance Department
3.0 AREA OF OPERATION
Maintenance Department.
4.0 RESPONSIBILITY
Operator/Maintenance Supervisor concerned.
5.0 ACCOUNTABILITY
Maintenance Incharge.
6.0 NORMAL OPERATION
Put ON Green push button of raw material pump. Open valves 1 & 2, get filtered water from the plant.
7.0 AIR SCOURING
a) Open valves V6 and V5 to loosen the accumulated dirt from the filter media. This operation is carried out for 1.5 to 3.0 minutes at the rate 2 m_3_/hr. at 0.35 kg/cm_2” pressure.
8.0 BACK WASHING OPERATION
8.1 Close valves 1 & 2 and open valves 3 & 4 to remove accumulated dirt and clean filter bed till clear water comes out in the drain. It will take about 5 minutes.
8.2 Back wash the filter after every week in running of the plant.
9.0 REVIEW DATE
After 2 years or when procedure is changed.

OPERATING PROCEDURE FOR MULTICOLUMN DISTILLATION STILL

1.0 AIM
To lay down a standard operating and cleaning procedure for Multicolumn distillation still.

2.0 SCOPE
Maintenance Department

3.0 AREA OF OPERATION
Multiple column and surrounding area.

4.0 RESPONSIBILITY
Operator/Maintenance Supervisor concerned.

5.0 ACCOUNTABILITY
Maintenance Head.

6.0 PRE-START UP

6.1 Check the cleanliness of still.

6.2 Check dry saturated steam supply after PRV it should be 4.8 to 6 Kg/Cm_2_.

6.3 Check the conductivity of D.M. Water and it's supply.

6.4 Compressed air supply should be 6 Kg/Cm_2_.

6.5 Check the cooling water supply; and it's pressure should be 1 to 1.8 Kg/Cm_2_.

6.6 Check the emergency stop button is in released position.

7.0 START UP

7.1 Keep the main switch ON position.

7.2 Keep the control on rotary switch in ON position.

7.3 Set high and low steam temperature limits on Temp. Indicator Controller

7.4 Set high and low distilled water temperature limits on Temp. Indicator Controller.

7.5 Set conductivity limits of inlet D. M. Water and outlet distilled water in conductivity meter.

7.5 Drain & close valves of 1st, 2nd and 3rd column.

7.6 Press start push button.

8.0 OPERATIONS

8.1 Metering pump and feed water inlet valve to be ON.

a) D.M. Water will fed to 1st column through cooler.

b) Water level of 1st column increases upto outlet of 1st column. When it reaches to float switch level; the D.M. Water inlet valve close and metering 3rd pump will stop. Water enters to 2nd column theree. Overflow of 1st column filled by water there. Overflow of 2nd column; like wise all 4 column filled & 4th column overflow collected as distilled water.

8.2 Open the steam inlet valve then steam enter into heat exchanger of 1st column. This will up the water in 1st column & converts it into steam.

8.3 Drain the condensates & Plant steam through steam trap.

8.4 The water level of 1st column drops below float switch level hence pump starts again & D. M. Water fed into 1st column.

8.5 Steam produced in 1st column then enters to heat exchanger of 2nd column & it converts D. M. Water of 2nd column into steam form. Condensate of 2nd column is collected in cooler.

8.6 Steam produced in 2nd column enters to heat exchanger of 3rd column; that converts D. M. of 3rd column into steam form condensor of 3rd is collected in the cooler.
8.7 Steam produced in 3rd column enters to heat exchanger of 4th column which converts D. M. Water of 4th column into steam form. The condensate of 4th column is collected in the cooler.

8.8 Adjust the opening of the cooling water inlet valve with such that temp. of distilled water should be 90_0” +/- 5_0_C.

9.0 SHUT DOWN

9.1 Close the plant steam inlet valve.

9.2 Close the water inlet valve.

9.3 Open the drain valve of all 4 columns & drain D. M. Water from each column. Run metering pump and drain D. M. from each column to avoid formation of scaling in column and heat exchanger.

9.4 Switch OFF the metering pump.

9.5 Close D.M. Water inlet valve.

9.6 Close all column drain valves.

9.7 Switch OFF the control panel supply & 3 phase supply.

9.8 Close the compressed air inlet valve.

10.0 REVIEW DATE
After 2 years or when procedure is changed.

OPERATING PROCEDURE FOR L. V. PANEL

1.0 AIM
To lay down a standard operating procedure for L.V. Panel.
2.0 SCOPE
Maintenance Department
3.0 AREA OF OPERATION
Maintenance department.
4.0 RESPONSIBILITY
Operator/Maintenance Supervisor concerned.
5.0 ACCOUNTABILITY
Maintenance Incharge.
6.0 CHANGE OVER OPERATION M.S.E.B. & D.G. SET.
6.1 If M.S.E.B. supply fails, the Air Circuit Breaker on L. V. Panel gets trip automatically and OFF indication comes. Then turn the interlock key anti clockwise and remove from A.C.B. key slot.
6.2 Start D. G. Set, raise voltage to read to 415 volts on voltmeter (placed on change over side) on the L. V. Panel Board, Push the interlock key in the key slot of change over switch. (Marked as D. G. Set) and turn it clockwise. Make
the change over switch ON.
6.3 When M.S.E.B. supply comes the Voltmeter on Air Circuit Breaker (A.C.B.) side indicates the voltage. Check the voltage indicated to 415 volts. Switch OFF change over switch and turn interlock key anti clockwise and remove from
key slot.
6.4 Insert the interlock key in the slot of Main Air Circuit Breaker and turn clockwise. Take the Air Circuit Breaker to ON handle upwards in anti clockwise direction and then push down in clockwise direction to switch ON the A.C.B. The ON indication comes on Air Circuit Breaker.
7.0 CAPACITORS
7.1 When power factor (P. P.) of the panel is indicated as 0.9 and above, keep the capacitor switches in OFF position.
7.2 When P. F. is between 0.85 to 0.9 keep two banks of capacitor switches in ON position.
7.3 When P. F. is below 0.85 keep all four banks of capacitor switches in ON position.
8.0 REFERENCE
F-ME-017 - Format for Daily Log Book D. G. Set.
9.0 REVIEW DATE
After 2 years or when procedure is changed.

OPERATING PROCEDURE FOR BOILER

1.0 AIM
To lay down a standard operating procedure for Boiler.
2.0 SCOPE
Maintenance Department
3.0 AREA OF OPERATION
Boiler House.
4.0 RESPONSIBILITY
Operator/Maintenance Supervisor concerned.
5.0 ACCOUNTABILITY
Maintenance Incharge.
6.0 STARTING PROCEDURE: (BOILER)
6.1 Open the valves on water supply line and fuel supply line.
6.2 Put the electric main switch 'ON'.
6.3 Close the main steam valve and open the auxiliary steam valve.
6.4 Put the FILL switch 'ON' to fill up the coil and check the water is coming out from the auxiliary drain pipe.
6.5 Press FUEL CIRCULATION switch for about half a minute.
6.6 Put the FIRE switch ON. Check the BURNER ON Green lamp comes ON. If Heater gives a larm check the boiler trouble shooting problem, rectify it and then start the boiler again.
6.7 Observe the steam is coming out from the auxiliary valve drain pipe. Then stop the auxiliary valve and open main steam valve.
6.8 Check the following operating conditions of boiler during the operation.
a) Burner starts at steam pressure 6.0 Kg/cm_2_.
b) 6.8.2 Burner stops at steam pressure 7.0 kg/cm_2_.
c) 6.8.3 Low water level and high temperature indicator does not comes ON.
6.9 Note-down the operating conditions in the log-book.
7.0 STOPPING PROCEDURE OF BOILER
7.1 Close the steam stop valve. Pressure switch will cut off the boiler.
7.2 Put the FIRE switch off.
7.3 Open the coil blow-down valve full and blow-down the boiler, close the blow-down valve and open the auxiliary steam valve fully. Drain the economiser by keeping its drain valve open till clear water starts coming out.
7.4 Put the FILL switch ON to fill up the coil.
7.5 Put OFF electric main switch and close the outlet valves of soft water service tank and fuel oil service tank.
8.0 REFERENCE
FORMAT FOR DAILY LOG BOOK BOILER.
9.0 REVIEW DATE
After 2 years or when procedure is changed.

OPERATING PROCEDURE FOR AIR COMPRESSOR

1.0 AIM
To lay down a standard operating procedure for Air Compressor.
2.0 SCOPE
Maintenance Department
3.0 AREA OF OPERATION
Maintenance area.
4.0 RESPONSIBILITY
Operator/Maintenance Supervisor concerned.
5.0 ACCOUNTABILITY
Maintenance Incharge.
6.0 STARTING PROCEDURE: (AIR COMPRESSOR)
6.1 Remove moisture Air receiver by opening the drain valve.
6.2 Observe crank case oil is 3/4 to 1/2 level of sight glass if not make crak case oil level with fresh oil.
6.3 Turn on full supply of cooling water by opening gate valve on cooling water line.
6.4 Put main switch ON press the green bush button of pressure control switch, then push the start push button & press the pressure control push button till the motor goes from start to Delta connection.
6.5 Operate the Air Compressor in following operating conditions-
a) Oil pressure should be in between - 15 to 40 PSI
b) Loading and unloading pressure should be in between6.2 kg/cm”2_.
6.6 Note down the operating conditions in dialy log-book.
7.0 STOPPING PROCEDURE: (AIR COMPRESSOR)
7.1 Unload the air compressor by the spring adjuster nut at Auxiliary valve.
7.2 Stop the air compressor by RED bush button and switch OFF the main switch.
7.3 Close cooling water line gate valves.
8.0 REFERENCE
F-ME-010 : FORMAT FOR DAILY LOG-BOOK AIR COMPRESSOR.
9.0 REVIEW DATE
After 2 years or when procedure is changed.

OPERATING PROCEDURE FOR A/C COMPRESSOR

1.0 AIM
To lay down a standard operating procedure for A/C Compressor.
2.0 SCOPE
Maintenance Department
3.0 AREA OF OPERATION
Air conditioning room.
4.0 RESPONSIBILITY
Operator/Maintenance Supervisor concerned.
5.0 ACCOUNTABILITY
Maintenance Incharge.
6.0 STARTING PROCEDURE: (A/R COMPRESSOR)
6.1 Put ON main switch in the control panel. Main switch should kept on for one hour before starting the A/C compressor for heating the crank case oil.
6.2 Confirm compressor crank case oil level is 1/2 to 3/4 of the sight glass.
6.3 Make the minimum basin level of the cooling tower sump by opening the Gate Valve on the water supply line.
6.4 Start all AHU in various departments.
6.5 Open gate valves on cooling water and chilled water line.
6.6 Start cooling water pump, cooling tower and chilled water pump by Green push button in the control panel.
6.7 Put ON all the toggle switches in the control panel.
6.8 Press P.D.S. repeatedly to equalize the system. Start A/C compressor by pushing start Green Push Button. Press P.D.S. till compressor motor goes from start to delta connection.
6.9 Note down all operating pressure and temperatures in the daily log-book.
7.0 STOPPING PROCEDURE
7.1 Put PSV OFF compressor will trip on LP.
7.2 Switch OFF cooling water pump and cooling tower fan.
7.3 Stop chilled water pump and all AHU after 15 minutes.
7.4 Put OFF main switch.
8.0 REFERENCE
F-ME-009: FORMAT FOR DAILY LOGBOOK A/C COMPRESSOR.
9.0 REVIEW DATE
After 2 years or when procedure is changed.

SOP DG Set

1.0 Procedures

a) Before Starting the Engine ,ensure the generator is set up for the correct voltage, Check owners operation manuals and wiring diagrams for the correct hook ups prior to starting the generators.

b) Ensure the generator output breaker is in the OPEN position.

c) Never start or stop a generator with the output breaker in the CLOSED position.

d) Check all liquid levels of the diesel engine: water, oil, fuel. Add any fluid if required.

e) Ensure the generator, radiator, and control cabinet louvers are open for proper air flow across the engine and generator.

f) While performing the generator checks, wear work gloves and safety shoes. When checking the battery, or adding water to it wear acid resistant gloves and safety goggles. Check Generator Voltage and Phase Rotation

g) Start the generator and check the generator voltage(all phases), cycles, and phase rotation. Adjust voltage with "Voltage Adjustment Knob", located on the control cabinet. d) If required, check phase rotation of generator and load.

h) Secure the generator.

i) Connect the generator to the load. Observe the phase rotation. Use proper bending and lifting techniques when handling cables.

Wear safety shoes and work gloves. Put on hearing protection when generator is running. When checking phase rotations if the voltage is greater than 300 volts, then personnel doing the checks will wear coveralls, hood,insulating rubber gloves and sleeves, safety glasses, safety shoes, and hard hat.

Close the generator output breaker in accordance with generator operation manuals.:

SOP :Basket Centrifuge

Principle:

Filterable products are separated in a perforated basket. The liquid/solid slurry is introduced into the rotating body of the centrifuge via a feed pipe. The centrifugal force pushes the slurry to the side, forcing the liquid through the perforations in the basket while the solids are retained within by means of a fine screen or cloth.

The remaining solids (cake) can then be washed and spun at higher Cs to achieve a relatively dry cake. The resultant cake is then discharged through the bottom of the basket by means of a single motion plow mechanism.

1. Install a clean filter bag
2. Securing the lid
3. Connect the three process lines on the cover,
4. Start the centrifuge.
5. Adjust the machine speed via the speed controller.
6. When the tachometer indicates that the machine is at feed speed, the process slurry is introduced into the rotating bowl.

7. Solid particulate accumulates in a uniform ring on the bowl’s inside diameter while liquid filters through the porous solid cake and exits the centrifuge discharge outlet.
8. When the solids holding space is completely full, the feed is stopped, the washing cycle is started and adjusted to a higher speed to obtain the dryest cake possible.
9. At the end of the cycle, the centrifuge is stopped and the filter bag with the solids is removed.

Notes:

Use interchangeable solid or perforated baskets appropriately.

PREPARATION OF SOP

1.0 OBJECTIVE:
To lay down an approved procedure for the Preparation, Distribution, Review, Retrival and Archival of Standard Operating Procedure
2.0 SCOPE:
This procedure is applicable to the preparation, distribution, review, retrival and archival of Standard Operating Procedure used in Quality Assurance, Quality Control, Production and Stores Departments.
3.0 RESPONSIBILITY:
Manager-Quality Assurance
4.0 ACCOUNTABILITY:
General Manager
5.0 DEFININTIONS:
5.1 Standard Operating Procedure: Standard Operating Procedure is a logical sequence of events in instructional form for performing the activities.
5.2 Master Copy: The first copy of Standard Operating Procedures that bears original signatures are stamped ‘MASTER COPY’ in red ink, at the top left corner.
5.3 Controlled Copy: A photocopy of the Master Copy along shall be stamped as ‘CONTROLLED COPY’ in Green ink with Sign and Date at the bottom left corner that shall be used with in the organization and is distributed to a limited number of authorized document holders.
5.4 Display Copy: A photocopy of the Master Copy stamped as ‘DISPLAY COPY’ at the Top Right corner in Red ink.
5.5 Uncontrolled Copy: A photocopy of the Master Copy for the use of customers / external agencies shall be stamped as ‘UNCONTROLLED COPY’ in Red ink across the centre of each page.
5.6 Training Copy: A photocopy of the Master Copy shall be stamped as ‘TRAINING COPY’ in Red ink in the bottom right corner of each page. The training shall be conducted to all users in the department.
5.7 Obsolete copy: The superseded Master copy of any document or a copy of any discontinued document that is taken out of use is stamped as ‘OBSOLETE COPY’ in red ink in the bottom right corner of each page.
6.0 PROCEDURE :
6.1 Design of standard operating procedure:
6.1.1 The standard operating procedure shall be created in specific format (refer)
QA GP:001:F01:00
6.1.2 SOP shall be prepared by using Microsoft word on A4 size paper. The text shall be in ‘Normal’ style with ‘Times new roman’ ‘Regular’ font size of 12. Single line spacing shall be assigned between lines and paragraphs.
6.1.3 The header shall contain company logo, name and location, title, page number, sop number, revision number, date of issue and effective date.
6.1.4 Footer shall have the provision for the signature, date and designation of the prepared by, checked by and approved by.
6.1.5 Each page of standard operating procedure shall be consecutively numbered indicating page the number and the total number of pages in the sop. E.g. page 1 of 2and 2 of 2.
6.1.6 The sections shall be serially numbered using Arabic numeral starting for 1.0and the subsections of each section shall also be serially numbered as 1.1, 1.2, and so on. Its subsections shall further be numbered as 1.1.1, 1.1.2 and so on.
E.g. 1.0
1.1
1.1.1
6.1.7 After the completion of the sop shall be signed and dated along with the designation of the signatories.
6.2 Identification of Standard Operating Procedure:
The standard operating procedures shall be written in nine sections. Refer format QAGP:001:F01:00.
6.2.1 Purpose: objective of writing the particular sop. It should start with the phrase ‘to lay down an approved procedure…………..’
6.2.2 Scope: the area / equipment/ instrument/ facility/ system/ department/ personnel to which the procedure applies.
6.2.3 Responsibility: the designation of the person(s) who are directly responsible for carrying out the activity mentioned in the purposed of the sop.
6.2.4 Accountability: The designation of the person(s) who are accountable for complying the sop.
6.2.5 Definitions: Meaning of the unique terms used in the sop.
6.2.6 Procedure: Detailed stepwise activities to be performed and shall be written in a simple language with simple sentence structure step by step.
6.2.7 Reference: Other documents referred for the preparation of the sop.
6.2.8 Enclosures: Formats required for recording the information such as formats, lists, tables, checklists and labels shall be attached with the sop.
6.2.9 Abbreviations: Full form of the abbreviations shall be used in first afterwards short forms shall be used. All abbreviations used in the sop shall be mentioned in this section.
6.3 Numbering of Standard Operating Procedure:
6.3.1 SOP shall be identified by an alphanumeric numbering system.
6.3.2 SOP shall be numbered with 4 alphabets; first 2 alphabets specify department and other 2 alphabets specify the functional subgroup and Arabic numerical serial number in 3 digits starting from 001.
6.3.3 Department code for Quality Assurance Department shall be ‘QA’ and it should be the first two letters of all the SOPs indicating that the particular SOP belongs to Quality Assurance Department.
6.3.4 Functional subgroup code (2 alphabets) shall be assigned as per functional area where the sop is applicable.
6.3.5 The following functional subgroup codes that shall be used in SOP:
GP: General Procedures
EO: Equipment Operating Procedure
IO: Instrument Operating Procedure
EC: Equipment Cleaning Procedure
CL: Calibrating Procedure
6.3.6 The department code along with functional subgroup code shall be the first part, which will then be followed by a colon further followed by serial number.
E.g. PREO:001, where PR- Department Code ( i.e. Production Department)
EO- Functional Subgroup Code (Equipment Operation)
001-Arabic numeral serial number (Specifies a particular SOP)
6.3.7 Design and Numbering of formats:
6.3.7.1 The format shall have header with company logo, name of the organization, title of the format, page number and effective date. The format number along with the revision number shall be mentioned in the bottom right corner of each page (Refer Format No. QAGP:001:F02:00)
6.3.7.2 Format shall have identification SOP number based on the procedures under which they are prepared. Format prepared under a procedure shall be serially numbered. Final copy of the format shall bear the signature of the authorized person along with date, specifying the copy as Master Copy.
6.3.7.3 Formats shall be issued as electronic copies with the QA issued, sign and date stamping on the formats. QA personnel shall sign and date during issue.
6.3.7.4 The photocopy of the master format shall be taken and stamped as ‘CONTROLLED COPY’ in Green ink along with sign and date.
6.3.7.5 The photocopies of the controlled copy format shall be stamped with QA issued with sign and date and distributed to the departments.
6.3.7.6 The department code along with functional subgroup code which is 4
alphabets shall be the first part, which will then be followed by colon further
followed by a serial number and a colon, and then format number in alpha numeric followed by a colon, and the revision number. E.g. the first format of an SOP designed shall have the format number as, QAGP:001:F01:00.
6.3.7.7 The labeling formats shall be same as the order of the format.
E.g. QAGP:001:L01:00.
6.3.7.8 If the format undergoes a change, the revision number shall be changed to the next number.
6.4 Preparation and Distribution of Standard Operating Procedure:
6.4.1 The person responsible for the preparation of SOP shall prepare a Draft Copy and stamp it as DRAFT COPY in Red ink, in the left column provided in the footer of each page and circulate for suggestions or corrections if any.
6.4.2 Necessary corrections shall be made based on the feedback and a final print out to be taken and the Draft Copy to be destroyed.
6.4.3 The final copy of the SOP shall be signed in original shall be termed as master copy. This shall be indicated by stamping ‘MASTER COPY’.
6.4.4 Once the SOP is authorized and stamped as ‘MASTER COPY’, no manual corrections shall be allowed in the SOP.
6.4.5. Master list of SOPs shall be prepared as an index as per the format QAGP:001:F03:00. The master list shall be prepared for each department and functional subgroups and shall be coded as first three letters MLS indicating Master List of SOP followed by a colon and the department and functional subgroup and a colon followed by three digit numerical revision number starting from 001. If the Master List undergoes revision the serial it shall be changed into the next revision number. E.g. The Master List of SOPs for the Quality Assurance General Procedure Department shall be written as MLS:QAGP:001.
6.4.6 The required number of copies required to be distributed to be made by photocopying the Master Copy and enter the details in the ‘SOP Issue and Withdrawal Control Sheet’(refer Format QAGP:001:F04:00) and attached with each Master copy of the SOP.
6.4.7. If a copy of a particular SOP is required by outside agency then the copy shall be stamped as ‘UNCONTROLLED COPY’ with the consent and in consultation with QA Manager.
6.4.8 No SOP shall be copied by anyone other than the concerned person for any purpose. If such copies are made they will be treated as unauthorized / unofficial.
6.4.9 All the previous versions ‘CONTROLLED Copies’ and ‘Display Copies’ shall be retrieved and destroyed while issuing the new amended versions. The old version Master copies shall be stamped as ‘OBSOLETE COPY’ and retained with the department for future reference only.
6.5 Review of Standard Operating Procedure:
6.5.1 SOP shall be periodically reviewed before 15 days of completion of two years or as and when there is any relevant intermittent change in the SOP required.
6.5.2 The concerned head of the department shall review the ‘SOP Review Sheet’ Refer format QAGP:001:F05:00.
6.5.3 If any change is required it shall be noted in the change control form as per the change control procedure. Any change in the SOP/format, the SOP shall be revised to the next revision number.
6.5.4 If the SOP undergoes review, the revision shall be mentioned in the revision number column as 01 for first version, 02 for second version and so on for new SOP revision number will be 00. if any SOP number is required to specify in some other document for reference, only the SOP number shall be specified without the revision number.
6.6 Changes to the SOP:
6.6.1 Any change to the SOP shall be made as per instructions given in Change Control SOP
6.6.2 Whenever any SOP/format undergoes a change the revision number shall change to the next number. A brief description of the change recorded in the SOP Review Sheet.
6.6.3 The amended documents shall be distributed as per the instruction in section 6.4 onwards.
6.6.4 All the controlled copies and Display copies of the superceded SOP shall be withdrawn and destroyed before issuing the amended SOP.
6.6.5 The Master Copy of the superceded SOP shall be stamped as Obsolete Copy and shall be held in the department for future reference. A record of destruction shall be made in column provided in the SOP Control Sheet and attached to the obsolete copy.
6.6.6 Master List of SOP shall be revised and maintained separately.
6.7 Retrieval of Standard Operating Procedure:
6.7.1 All the previous versions Controlled Copies and Display copies shall be retrieved and destroyed before issuing the new amended versions. The Master Copies shall be stamped as ‘OBSOLETE COPY’ and retained in the department for future reference.
6.8 Storage of Standard Operating Procedures:
6.8.1 All master copies of the SOP to be stored under lock and key. It shall be easily retrievable but access to be limited only to the authorized persons.
6.8.2 Obsolete copies shall be filed and stored separately from that of the current versions of the master copies.
6.9 Control of data in computer:
6.9.1 Any instruction/information/data stored in computer hard disc/electronic copies shall not be considered as official for regulatory purposes. The approved copies that are signed shall be considered as official documents.
6.10 Archival of Standard Operating Procedures:
6.10.1 Obsolete SOP shall be stored for 5 years from the superceded date.
6.10.2 After the storage period the obsolete SOP shall be torn into pieces and put to fire for
destruction.
7.0 REFERENCES:
Nil